Multifocal Chromatic Pupilloperimetry in Patients With Pseudotumor Cerebri and Healthy Subjects.

NCT03304314 | Recruiting

• 1 other identifier: SHEBA-17-3754-YR-CTIL
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

PTC(Pseudotumor cerebri) patients may develop increased Intracranial pressure (ICP) that can produces increased pressure around the distal optic nerve,which is likely followed by venule compression, ischemia, and loss of visual function.Vision loss in PTC is most commonly characterized by standard automated perimetry to measure peripheral visual field sensitivity. Pupillometry is a promising approach for functional assessment in PTC because it is noninvasive, objective, performed quickly with minimal patient cooperation needed. The feasibility of using chromatic multifocal pupillometry for assesment of PTC will be examined.

Conditions

Pseudotumor Cerebri

Keywords

PTC; EYES; Pseudotumor cerebri; increased Intracranial pressure; ICP

Outcome Measures

Primary Outcomes (3)

• Measurement of maximal precentage of pupil contraction and dilation in response to chromatic light stimulus

  Percentage of pupil contraction and dilation in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients and compared to matched controls

  single visit: 1 day

• Measurement of maximal velocity of pupil contraction and dilation in response to chromatic light stimulus

  Pupil contraction and dilation velocity (in pixel/second) in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients and compared to matched controls

  single visit: 1 day

• Measurement of latency of pupil contraction and dilation in response to chromatic light stimulus

  Pupil contraction and dilation latency (in seconds) in response to blue and red light displayed at 76 test targets in a visual field of 30 degree will be measured in PTC patients and compared to matched controls

  single visit: 1 day

Secondary Outcomes (11)

• Subjective visual field

  single visit: 1 day

• Optic nerve structure by OCT

  single visit: 1 day

• Change from baseline pupil contraction and dilation precentage in PCT patients at 48 hours

  single visit: 1 day, 48 hours after baseline testing

• Change from baseline pupil contraction and dilation maximal velocity in PCT patients at 48 hours

  single visit: 1 day, 48 hours after baseline testing

• Change from baseline pupil contraction and dilation latency in PCT patients at 48 hours

  single visit: 1 day, 48 hours after baseline testing

Study Arms (2)

Pseudotumor cerebri (PTC) patients

EXPERIMENTAL

Diagnostic Test: objective chromatic multifocal pupillometer

Control

EXPERIMENTAL

Diagnostic Test: objective chromatic multifocal pupillometer

Interventions

objective chromatic multifocal pupillometer DIAGNOSTIC_TEST

objective chromatic multifocal pupillometer (OCMP) enables objective and accurate measurement of pupillary responses to chromatic light at different wavelengths and light intensities and at different visual field locations.

Control; Pseudotumor cerebri (PTC) patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy subjects
• Male or female patients, age between 18 and 80 years, inclusive
• Informed written consent will be obtained from all participants.
• Normal eye examination
• Best-corrected visual acuity (BCVA) of 20/20
• Normal color vision test (Ishihara/HRR)
• Normal Spectral-Domain Optical Coherence Tomography (SD-OCT)
• Normal 24-2 Humphrey visual field (SITA Standard) and:
• Short duration (≤10 minutes)
• Minimal fixation losses, False POS errors and False NEG errors (less than 33% for each one of reliability indices)
• PTC patients
• Male or female patients, age between 18 and 80 years, inclusive
• Best-corrected visual acuity (BCVA) of at least 20/100 in worse eye
• Optic disc edema
• PTC diagnosis based on Modified Dandy Criteria ( lumbar puncture with opening pressure higher than or equal to 25 cm H2O, normal cerebrospinal fluid constituents, and unremarkable brain imaging results except typical for PTC

You may not qualify if:

• Healthy subjects
• History of past (last 3 months) or present ocular disease or ocular surgery
• Use of any topical or systemic medications that could adversely influence pupillary reflex
• Intolerance to gonioscopy, slit lamp examination, Goldmann applanation tonometry or other schedule study procedure.
• Mental impairment or instability such as that informed consent may not be obtained or compliance with tester instructions is unlikely.
• Visual media opacity including cloudy corneas.
• Any condition preventing accurate measurement or examination of the pupil.
• PTC patients
• Any other neurologic or ophthalmic disease other than PTC
• Use of any topical or systemic medications that could adversely influence pupillary reflex
• Intolerance to gonioscopy, slit lamp examination, Goldmann applanation tonometry or other schedule study procedure.
• Mental impairment or instability such as that informed consent may not be obtained or compliance with tester instructions is unlikely.
• Visual media opacity including cloudy corneas.
• Any condition preventing accurate measurement or examination of the pupil.

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Tel Litwinsky, 52621, Israel

RECRUITING

MeSH Terms

Conditions

Pseudotumor Cerebri; Intracranial Hypertension

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Ygal Rotenstreich, MD

CONTACT

972-35302880; ygal.rotenstreich@sheba.health.gov.il

Ifat Sher, PhD

CONTACT

ifat.sherrosenthal@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of ElectrophisiologyClinic and Retinal Research Laboratory

Study Record Dates

• First Submitted: September 17, 2017
• First Posted: October 9, 2017
• Study Start: November 3, 2017
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)